title: A Randomized, Crossover, Single-Dose Bioequivalence Study of Two Extended-Release Tablets of Donepezil 23 mg in Healthy Human Volunteers under Fasting and Fed States.
abstract: To assess the bioequivalence of two extended-release tablets of donepezil 23 mg, open label, randomized, single-dose, two-sequence, two-period crossover studies under fasting (n=74) and fed (n=94) conditions in healthy adult human volunteers were conducted. Subjects were randomized to either of the two treatment arms (test or reference) separated by a washout period of 28 days. Blood samples were collected up to 72 h post-dose and plasma samples were analyzed for donepezil using a validated LC-MS/MS method. Pharmacokinetic parameters were derived using a non-compartmental approach. Bioequivalence was evaluated in 69 subjects in the fasting study, and 71 subjects in the fed study. In the fasting study, the 90% CI of Cmax and AUC0-72 were 82.50-90.10 and 92.38-98.60, respectively. Corresponding values in the fed study were 91.82-98.05 and 97.27-100.27. Based on the results, the test product (donepezil) met the US regulatory criteria of bioequivalence relative to the reference product (Aricept(®)) under both fasting and fed conditions.
authors.affiliation: Clinical Pharmacology and Pharmacokinetics, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Hyderabad-500090, India.
authors.forename: Chaitanya
authors.initials: C
authors.lastname: Gadiko
authors.forename: Sudhakar Koundinya
authors.initials: SK
authors.lastname: Tippabhotla
authors.forename: Satyanarayana
authors.initials: S
authors.lastname: Thota
authors.forename: Ramakrishna
authors.initials: R
authors.lastname: Battula
authors.forename: Sohel Md
authors.initials: SM
authors.lastname: Khan
authors.forename: Venkateswarlu
authors.initials: V
authors.lastname: Vobalaboina
keywords: Bioequivalence; Donepezil; Non-compartmental; Pharmacokinetic